Supply-side and demand-side policies for biosimilars: an overview in 10 European member states

Figures & data

Table 1. List of biosimilars approved by the European Medicines Agency (as of June 2016) [13].

Medicine class	Reference medicine brand name (company)	Biosimilar brand name	International non-proprietary name	Marketing authorization holder	Marketing authorization date
Granulocyte-colony stimulating factor (G-CSF)	Neupogen® (Amgen)	Accofil®	Filgrastim	Accord Healthcare Ltd	18 September 2014
	Neupogen® (Amgen)	Grastofil®	Filgrastim	Apotex Europe BV	18 October 2013
	Neupogen® (Amgen)	Nivestim®	Filgrastim	Hospira UK Ltd	8 June 2010
	Neupogen® (Amgen)	Zarzio®	Filgrastim	Sandoz GmbH	6 February 2009
	Neupogen® (Amgen)	Filgrastim Hexal®	Filgrastim	Hexal AG	6 February 2009
	Neupogen® (Amgen)	Biograstim®	Filgrastim	AbZ-Pharma GmbH	15 September 2008
	Neupogen® (Amgen)	Ratiograstim®	Filgrastim	Ratiopharm GmbH	15 September 2008
	Neupogen® (Amgen)	Tevagrastim®	Filgrastim	Teva GmbH	15 September 2008
Epoetin	Eprex/Erypo® (Janssen)	Retacrit®	Epoetin zeta	Hospira UK Ltd	18 December 2007
	Eprex/Erypo® (Janssen)	Silapo®	Epoetin zeta	Stada Arzneimittel AG	18 December 2007
	Eprex/Erypo® (Janssen)	Abseamed®	Epoetin alfa	Medice Arzneimittel Pütter GmbH & Co. KG	28 August 2007
	Eprex/Erypo® (Janssen)	Epoetin alfa Hexal®	Epoetin alfa	Hexal AG	28 August 2007
	Eprex/Erypo® (Janssen)	Binocrit®	Epoetin alfa	Sandoz GmbH	28 August 2007
Insulin	Lantus® (Sanofi)	Abasaglar®	Insulin glargine	Eli Lilly Regional Operations GmbH	9 September 2014
Anti-tumour necrosis factor (anti-TNF)	Enbrel® (Pfizer)*	Benepali®	Etanercept	Samsung Bioepis UK Ltd (SBUK)	14 January 2016
	Remicade® (Janssen)	Flixabi®	Infliximab	Samsung Bioepis UK Ltd (SBUK)	26 May 2016
	Remicade® (Janssen)	Inflectra®	Infliximab	Hospira UK Ltd	10 September 2013
	Remicade® (Janssen)	Remsima®	Infliximab	Celltrion Healthcare Hungary Kft.	10 September 2013
Gonadotropins	Gonal-f® (Merck Serono)	Bemfola®	Follitropin alfa	Finox Biotech AG	27 March 2014
	Gonal-f® (Merck Serono)	Ovaleap®	Follitropin alfa	Teva Pharma BV	27 September 2013
Human growth hormone (hGH)	Genotropin® (Pfizer)	Omnitrope®	Somatropin	Sandoz GmbH	12 April 2006

Table 2. Terms used to search particular databases and publications dated between 2005 and September 2016.

Database	Search terms
MEDLINE	Biosimilar, off-patent biologic, follow-on biologic, similar biologic, similar biotechnological, subsequent entry biologic, incentive, uptake, penetration, policy, pricing, reimbursement, tender, reference pricing, price referencing, price linkage, health technology assessment, INN prescribing, purchase, procurement, demand-side policy, supply-side policy, substitution, Europe, European Union, Germany, France, Italy, Spain, Sweden, Poland, Hungary, Belgium, Greece, United Kingdom, UK
Embase
Cochrane Library
GaBi Journal and GaBi website	Biosimilar, incentive
ISPOR	Biosimilar
HTAi	Biosimilar, off-patent biologic, follow-on biologic, subsequent entry biologic, incentive

Figure 1. Flowchart of search results.

Table 3. Key supply-side policies for biosimilars.

Policy	Belgium	France	Germany	Greece	Hungary	Italy	Poland^a	Spain	Sweden	UK
IRP	×	✓	✓	×	✓	×	✓	✓	×	×
ERP	×	×	×	✓	×	✓	✓	×	×	×
HTA	✓	✓	×	×	×	✓	✓^b	×	✓	✓
Price linkage	✓	✓	✓	×	✓^c	✓^c	✓^c	✓	✓	✓
Price re-evaluation	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Tendering	✓	✓	✓	×	✓	✓	✓	✓	✓	✓

IRP: internal reference pricing; ERP: external reference pricing; HTA: health technology assessment; ×: absence of policy; ✓: presence of policy.

^a Polish regulations do not differentiate between small molecule generics and biosimilars.

^b Only when there is no equivalent medicine on the market.

^c Mandatory price reduction (defined price cut).

Table 4. Key demand-side policies for biosimilars.

Policy	Belgium	France	Germany	Greece	Hungary	Italy	Poland^a	Spain	Sweden	UK
Pharmaceutical prescription budgets	×	×	✓	✓	×	✓	×	✓	✓	✓
Prescription quotas	✓	×	✓	–	✓	✓	×	✓	✓	×
Monitoring of prescriptions patterns	✓	×	✓	✓	–	✓	×	✓	✓	✓
Financial incentives or penalties aimed at physicians	✓	×	✓	✓	×	✓	×	✓	✓	✓
Prescription conditions/guidelines	✓	✓	✓	✓	✓	✓	×	×	✓	✓
Switching^b	✓	✓	✓	–	✓	✓	✓	✓	✓	✓
INN prescribing	×	×	×	×	×	×	✓	×	×	×
Biosimilar substitution	×	✓^c	✓^d	×	×	×	–^e	×	✓^d	×
Financial incentives or penalties aimed at pharmacists	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Patient co-payment	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
Information and education^f	✓	✓	✓	–	✓	✓	✓	✓	✓	✓

x: Absence of policy; ✓: presence of policy.

^a  Polish regulations do not differentiate between small molecule generics and biosimilars.

^b  Generally allowed under physician’s supervision; In Germany and Sweden, authorities allow switching for biosimilars coming from the same manufacturer.

^c  France is the first EU country to explicitly authorize by law biosimilar automatic substitution under specified conditions (automatic substitution not yet implemented in practice).

^d  Only for specific groups of biosimilars, i.e. produced by the same manufacturer.

^e  No regulation; automatic substitution may occur.

^f  Limited educational material related to the overall information about biosimilars found and generally not specifically targeting physicians, pharmacists, or patients. Education programmes/educational publications dedicated to physicians were found for Germany and the UK, and one brochure for patients published by Institute for Patients’ Rights and Health Education was found for Poland.

European Medicines Agency website Medicines. [Internet]. [ cited 2016 Jun 14]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&genericsKeywordSearch=Submit

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